Neuropathic Pain in Patients With Cancer
- Registration Number
- NCT00474916
- Lead Sponsor
- DARA Therapeutics
- Brief Summary
The purpose of this study is to collect beginning information on whether intravenous (IV) administration of KRN5500 is safe and effective for treatment of neuropathic pain in patients with cancer.
- Detailed Description
Neuropathic pain is a type of pain that results from nerve damage and is characterized by an abnormal hypersensitivity to harmless as well as harmful stimuli. This type of pain is extremely difficult to manage, fails to respond to standard analgesic medications or interventions, and often gets worse instead of better over time. Current approved therapeutic agents often have intolerable side effects and limited efficacy. Thus, there is an urgent need to develop safe and effective drugs to treat neuropathic pain.
Study DTCL100 will be conducted at multiple centers and will enroll patients that have advanced cancer AND neuropathic pain that has not responded well to previous treatment. Eighteen patients will be randomly assigned to receive up to 8 doses of active drug (KRN5500) or placebo. A maximum of 8 doses will be administered weekly over a 10 week period. Patients are encouraged to complete at least 4 treatment visits before a decision is made to complete the full 10 weeks of treatment and the 1 month followup period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 18 years or older
- Diagnosis of advanced or recurrent cancer
- No options for curative chemotherapy, but palliative chemotherapy allowed under certain conditions
- Refractory neuropathic pain rated 4 or greater on 0-10 scale and failure to respond to 2 commonly used treatments
- If taking opioids for pain, stable regimen over past week before enrolling
- Karnofsky performance status of 40 or more
- Females must be sterile or post-menopausal
- Radiation to site of neuropathic pain for past 4 weeks
- Major surgery within past 2 weeks
- Liver function and other key labs outside normal parameters
- ECG showing significant abnormality
- Myocardial Infarction (heart attack) within past 6 months
- History of interstitial lung disease
- History of severe allergic reaction to drugs containing polysorbate 80
- Other investigational drug within 2 weeks or 5 half-lives (whichever is longer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KRN5500 KRN5500 KRN5500 escalating dose of .6, 1.2, 1.8, or 2.2 mg/m2 in IV infusion of normal saline Normal Saline KRN5500 Placebo consists of IV infusion of normal saline Normal Saline Placebo Placebo consists of IV infusion of normal saline
- Primary Outcome Measures
Name Time Method Average pain intensity over the previous 24 hours as measured by a numeric rating scale (NRS) ranging from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain." Weekly for 10 weeks plus 30 day followup
- Secondary Outcome Measures
Name Time Method Physical Examination, Vital signs and body weight, Electrocardiogram, Laboratory parameters, Adverse events, Clinical Opiate Withdrawal Scale, rescue medication, Proportion of patients who achieved a 33% reduction in pain intensity Weekly for 10 weeks plus 30 day followup
Trial Locations
- Locations (12)
Cancer Institute Medical Group
🇺🇸Los Angeles, California, United States
University of California / Irvine Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Hematology and Oncology Specialists, LLC
🇺🇸Covington, Louisiana, United States
Ghassan Al-Jazayrly, M.D., Inc.
🇺🇸Los Angeles, California, United States
Keog Pharma, Inc.
🇺🇸Jupiter, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Carolina Pain Institute, PA
🇺🇸Winston-Salem, North Carolina, United States
St. Agnes Healthcare, Inc
🇺🇸Baltimore, Maryland, United States
Dr. Rivera-Colon
🇵🇷Rio Piedras, Puerto Rico
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
East Orange VA Medical Center
🇺🇸East Orange, New Jersey, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States